Anothe rSativex Article: Justin Gover: The world's most useful can

[grace]

Justin Gover does not look like a drug dealer. But he is, albeit a legal one. Neither does he look much like a hero. But he could well become one to the 100,000 people who suffer from multiple sclerosis in the UK after producing a medicine that has been shown to relieve the pain associated with the disease. The discovery may also put an end to MS sufferers' widespread dependence on cannabis, which many have used for decades to alleviate symptoms of the disorder.

 

In June, GW Pharmaceuticals, where Mr Gover is managing director, launched Sativex in the UK. It was a world first, being the only cannabis-based treatment to get a green-light by medical authorities for use as a prescription drug.

 

For more than a decade the company, an Alternative Investment Market group, has tried to persuade authorities in the UK, Europe and the key US market not only that cannabis helps to relieve the pain caused by MS, but that it could also produce a licensed treatment that could fit the requirements.

 

"We started from the perspective that thousands of patients can't be wrong," Mr Gover says. "Initially we had a Home Office licence allowing us to grow cannabis plants, and that gave us some initial media coverage. From that moment we had letters coming through from patients, saying 'thank goodness and let me tell you about my experience,' so for me the conviction was really quite simple: there would be challenges of course, but fundamentally there had to be a way of showing that what these patients had already been seeing for years actually worked."

 

He was offered the job by Geoffrey Guy, still the group's chairman and a scientist who has been developing medicines for more than 25 years. Mr Gover had just completed an MBA at the Insead business school, and those he graduated with moved into lucrative jobs with investment banks.

 

"A start-up like GW was an unlikely road for me to follow," he admits. "I'd set along one path with the MBA and then stepped off it straight away. As a number of people I knew were going off to work in the City, I found myself with Geoffrey sitting on our respective sofas with laptops. At that stage we didn't even have enough money for an office."

 

Mr Gover's early confidence that GW had a product that would eventually work has not meant that the path to commercial reality has always been an easy one.

 

The company had several fund-raising rounds, asking investors for £1m here and there, before listing the group in 2001. From then on, more equity raising, as well as a number of licensing and partnership agreements, have helped the group to fund trials of Sativex, all with the aim of proving that it was safe, and that it worked.

 

Before finally getting the UK licence in June, GW endured a lean spell of about five years during the middle of the last decade, when various trials went badly, or failed to show convincingly that cannabis-derived products could relieve pain.

 

"Whenever there's been a potential setback, we've always been able to say that six months down the line, there's another news event that might correct the bad news; we've always had a answer and always had a reason why backers should hold on to the shares."

 

As an industry, biotech is plagued by its often chronic lack of funding, and for every successful group that goes from having a good idea to commercial success, there are 10 that fail. Share prices tend to fluctuate largely on the result of drug trials, successful tests sending share prices north as the medicine's market release draws near, and unsuccessful tests causing them to fall as the drug fails to move on to the next level of development.

 

"It's difficult with biotech because each study is seen by the stock market as the sole determinant of whether a drug is going to succeed or not; its almost like a casino," Mr Gover says. "Everything you do is very visible; it's similar to having a dinner party where your guests watch you cook in the kitchen."

 

But, of course, there are companies that manage risks prudently, and those that promise the earth, and deliver much less.

 

Mr Gover refuses to criticise the City for its all-or-nothing approach to drug trials. Nor does he point a finger at other biotech firms, most of which have not managed to match promises and results. "If we wish to have a biotech sector, the financial markets have to be available, and [we need] institutions that are willing to take on the risks. It is vital, and in recent years, we've seen that as funds dry up, the number of younger biotech firms has diminished," he says.

 

After gaining its UK licence in June, Sativex was approved in Spain a month later. But getting the drug on the market is by no means the end of the road for GW, and Mr Gover emphasises that no champagne corks are popping yet.

 

When he first got the job, the company's focus was on Europe's 650,000 registered MS sufferers, many of whom habitually resorted to illegal cannabis smoking. Now, its attention is increasingly turning to the United States, the El Dorado for the pharmaceutical industry.

 

Under its Home Office licence to grow cannabis in Britain, GW runs two top secret sites, said to be near the south coast. But to get its research off the ground in the US, the company had to persuade the country's Drug Enforcement Administration (DEA) to issue its first import licence for what is known as a Schedule One substance, in other words a drug with a high potential for abuse and, crucially for GW, one that has no accepted medical use.

 

Though the measure may seem draconian, in California companies with Schedule One approval are allowed to cultivate marijuana for medicinal use thanks to the so-called Proposition 215, which was passed in 1996. The US did not figure in GW's original business plan, but Mr Gover says that as early as 2000 it had hired the lawyer who had been chief counsel to the Californian Medical Association when Proposition 215 was enacted, mindful that the day might come when having friends across the Atlantic would be useful.

 

Since then, GW has taken Sativex through various trials; a third phase of testing, which the company hopes will be the final one, is set to start imminently. If the company satisfies the US authorities that the drug works in this trial, a licence to use the treatment in the US is likely to follow – and that really will be the moment to serve the champagne.

 

"When we first went to see the DEA, we took letters of introduction from the Home Office, but there was still a lot of querying of just who we were, and we still have to justify that," says Mr Gover.

 

"In the early days we needed an armed guard for a nurse to move the material around a hospital – I don't think that happens any more. I suppose that shows how far we've come."

 

The CV: Justin Gover

 

* In January 1999, Justin Gover was appointed managing director of what was then a start-up biotech company, GW Pharmaceuticals, founded by Dr Geoffrey Guy and Dr Brian Whittle. It had a Home Office licence to grow cannabis but no office.

 

* He was previously head of corporate affairs, responsible for mergers and acquisitions and strategic investments at the Nasdaq-listed drug delivery company Ethical Holdings.

 

* Before joining Ethical Holdings, Mr Gover worked for BDO Management Consultants in Hong Kong and China.

 

* He holds an MBA from the French campus of the INSEAD business school.

 

* In 1992, Mr Gover received a BSc from Bristol University.

 

Date: 19 August 2010

Source: The Independent

http://www.independent.co.uk/news/people/p...er-2056259.html

[Radic]

they feel

so real

i just hope they deliver what they promise

btw

i havent herd any reports pon the effectiveness of sativex yet????????

have you???

make we know it

cause

if it is what they promise it is

a co2 botanical organic cannabis extract

Hash oil

thru a vaporizer

then i dont doubt its medicinal capabilities

imho

i'd really love to try it

guidance

[Radic]

greetnz

this is from info that GW supplied to the TGA

well i hafe correction to make

this is not hash oil thru a vaporiser at all

no nooooo

indeed

what GW is selling is simply cannabis tinctue

in a spray applicator

http://www.doctordeluca.com/Library/Addict...Monograph05.pdf

Medicinal ingredients:

 

SATIVEX® contains Cannabis sativa L. extracts

Tetranabinex® and Nabidiolex® equivalent to 27 mg/ml delta-

9-tetrahydrocannabinol (THC) and 25 mg/ml cannabidiol (CBD).

 

Important nonmedicinal ingredients:

 

Ethanol

Propylene glycol

Peppermint oil (flavouring)

This is a full listing of all nonmedicinal ingredients.

 

Dosage forms:

 

SATIVEX® is provided as a solution in a spray pump. It is

contained in an amber glass vial fitted with a metering pump

delivering 100 microlitres per actuation (spray). The pump is

protected with a plastic cap.

SATIVEX® is for buccal use. This means SATIVEX® is to be

sprayed into the mouth, under the tongue or on to the inside of

the cheek. Each 100 microlitre spray contains 2.7 mg delta-9-

tetrahydrocannabinol and 2.5 mg cannabidiol.

still looks good

seen

cannabis tincture is irey

so eze to make

and very very cheep to make too

so there better not be a big price tag

cause

we dont need GW to dowit for we

mullaway is making the same if not better and giving it away free to all suffers he meets

i make several different tinctures

it is eze, safe and fun to make

anyone could dowit

 

irey guidance

[snooch]

i havent herd any reports pon the effectiveness of sativex yet????????

have you???

 

A lot of the medical trials for MS and other ailments has shown a lot of success with sativex, but I did also find these couple of testimonials which I found interesting

 

http://www.londonpainconsultants.com/artic...le_joint_pains/

 

This one for:

 

Case report on the role of Sativex in a patient with polyarthropathy and multiple joint pains.

28th September 2006 at 18:53 BST by Dr.C.A.Jenner MB BS, FRCA. Permalink.

 

Case report on the role of Sativex in a patient with polyarthropathy and multiple joint pains.

 

I saw a 76 year old gentleman in the Pain Clinic, who had multiple pain problems including polyarthropathy and multiple joint pains.

In the past, he had tried a number of different medications and treatments including, Arthrotec, Diclofenac, Rofecoxib, Co-dydramol, Buprenorphine tablets and patches, Celecoxib, acupuncture and a lumbar epidural. Unfortunately, none of the medications had given him very much pain relief and had mostly given him adverse effects.

This gentleman was very keen to try Sativex which is purified form of Cannabinoid. Unfortunately, the drug was an unlicensed medication when he came to see me. We were able to obtain some directly from the manufacturers which the patient paid for themselves.

After 3 weeks on the Sativex, which was taken as a sub-mucosal spray, he was able to get reasonable pain relief by using it, up to 5 times a day. In his own words, he found the medication to be very beneficial in terms of reducing pain with minimal adverse effects.

The adverse effects included a change in taste and a dry mouth, although he felt that he could accept these. Generally speaking, he got pain relief within about 30 minutes of taking the spray. Overall, he felt better in himself as he felt he was able to manage the pain for himself.

The plan with this gentleman is to try and obtain the relevant authorisation to continue with this treatment.

 

These against:

http://www.msrc.co.uk/index.cfm?fuseaction...amp;pageid=2772

 

Anonymous - Cannabis Spray didn't work for me

I recently took part in a controlled medical trial, one of many currently funded by the NHS, using a cannabis extract sprayed under the tongue, to relieve symptoms of MS; in my case stiffness, spasms and bladder control.

The first shock came on the very first day of the trial. The written guidance I had been sent beforehand said that I should not drive for up to four hours after taking the spray. In fact it was only after that four hours were up that the full effect on my brain kicked in and I felt extremely weird for a further four hours after that. Apparently my delayed reaction was unusual.

This is my point. When it comes to drug use every individual is different. I've heard people say that cannabis helps them to think clearly. For myself the best way that I can describe it was like taking a shot of something designed to induce instant dementia!

Sitting at my computer I could not for the life of me remember what I was trying to do. My sense of proportion was distorted. This affected my sense of space. (How big was the room? I no longer felt clear of its dimensions); time (without looking at my watch I really had no idea whether minutes or hours had passed) and emotional too. When my daughter came home from school upset about something I could feel myself having to work desperately hard to think what to say although normally this would have been second nature to me.

After that first traumatic day I built my usage up very slowly, giving myself a chance to become tolerant of the drug so that I could see if there would be any benefits to my symptoms. I also concentrated my dosing at night so that I would be able to think clearly during the day.

In 10 weeks neither spasm nor stiffness improved although there was a slight benefit in terms of not having to get up at night and go for a pee. However, in spite of a longer night's sleep, I would feel more tired in the morning so that this couldn't particularly be seen as a gain.

Another symptom that worsened whilst I was taking the spray and improved after the ten week trial was astigmus, i.e. the eyes not tracking together properly; 'eye wobble' as I call it.

I asked the wife of a man involved in the trial what his experience had been. She was disconcertingly enthusiastic. "Oh, it's been marvellous", she enthused. "He's in bed by 9 o'clock every night these days." I make no judgement at all about the experience of this particular family but none the less her comment sounded a warning bell in my mind. As with the use of other medication the question has always to be asked, is the aim to improve health or to ease the burden on those in a caring role?

I am concerned in case important questions about widespread therapeutic use of cannabis, in particular its long term effects on fatigue, memory, the ability to respond to situations and stay in control of one's own life, get lost in the hype.

 

 

Lizzie Gilchrist - My Experience of Sativex

It must have been a couple of years ago that I first heard of Sativex. At this time I was already smoking Cannabis occasionally to help with twitchy legs at night. I have never really been a smoker so I was never terribly happy about doing this. So a cannabis spray seemed like the perfect solution to the problem. I tried to keep up to date on the latest Sativex news and hoped that it would soon become available.

At the start of summer 2005 a nurse I know told me about a Sativex trial going on in London and so I contacted them. After a long drawn out process they unfortunately turned me down for the trial. However in November 2005 the Home Office decided Sativex could be imported from Canada and prescribed to individual MS patients in the UK as an unlicensed medicine. I was one of the lucky few who managed to get through this process with no problems.

It took a week or two for my GP to make sure it was all ok and for the pharmacist to get the sprays from the warehouse but other than having to sign a disclaimer for the GP to say I understood this was an unlicensed drug it all went quite smoothly.

I was pretty excited to finally be getting Sativex and couldn't wait to start it. I had to build up the dose gradually to see how I tolerated it and to find the right dose for me personally. I had absolutely no side effects from it which I was very glad about, however, I didn't really feel any benefit from it either.

I ended up on quite a high dose of it in order to see if that would help. It may have slightly improved the spasticity in my legs during the day but not to any significant degree and unfortunately it didn't help the twitches in my legs at all.

I perservered with Sativex for a few weeks but unfortunately it just didn't help me. I know of various people it has helped greatly but like many things it just seems to be a case of different things helping different people.

[Radic]

irey thanx bro

yes i gotta love dat

the negative 2 only used it internally

i would advise each to use it (where possible)

externally too,

as well as internally

just rub it straight in to affected areas

i have used it topically with great success, as a rub for pain control,

an anti inflammatory for sore swollen mussels and joints,

antibiotic pon cuts and grazes,

and to control various skin fungi, ticks bits and even nits

 

http://earthreggae.com/img/ganga/tincture9.jpg

 

cannabis tincture rulez

i make 3 different tinctures

red, gold and green cannabis tinctures

 

http://earthreggae.com/img/ganga/tincture.jpg

 

this is green dragon

they all have different medicinal qualities and uses

mullaway makes a clear tincture

which works a treat pon everyting i've tried it pon

forward ever

free cannabis

heal the people

heal the land

[Radic]

1 more ting

the good people of oz should know

TGA Scheduling of Botanical extract of Cannabis

The Committee also considered whether to limit the Schedule 8 entry to a single indication – MS. Several Members noted, however, that there were ongoing trials for using nabiximols for other indications, including the treatment of unresponsive cancer pain.

 

A Member noted that any issue of indications etc., would be addressed by the regulator through the conditions imposed by the Appendix D, paragraph 3 entry.

 

The Committee agreed to not restrict the Schedule 8 nabiximols entry by indication.

that means that the doctors can prescribe Sativex for any ailment they tink cannabis may cure or ease

so if you can talk your doctor into applying to the relevant authorities you can get it

their advertising blub says --->organic cannabis tincture in a oral spray applicator

cannabis tincture is now available in oz with no restriction pon what it can be prescribed for

thanx and praize

 

forward ever

free cannabis

Heal the people

heal the land

[Stokes]

When i heard about Sativex i thought my dreams where comeing tru nut upon visiting the chemist i was presented with "NO australia wont except anything that has to do with MARIJUANA here look for yourself" then she turned the screen my way and showed me all the countries that does except it and australia wasnt on it. my MS was getting damn nervous but oh well i'll have to keep taking their poisins. and when i corrected her on the fact that its called cannabis or Kaneh bosm (silent m) when used for medical Edited March 16, 2012 by Stokes